Phase I Assessment of Thermal Signature of Patients Undergoing Radiation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- M.D. Anderson Cancer Center
- Locations
- 1
- Primary Endpoint
- Change in Participant Thermal Signature as determined by Thermal imaging (recording body temperature)
Study Overview
Brief Summary
The goal of this clinical research study is to evaluate whether thermal imaging (recording body temperature) can be used to check the body's response to cancer therapy.
Primary Objective:
- The primary objective of this study is to establish techniques and methodologies of quantifying thermal signatures and their changes for cancer patients undergoing chemoradiation therapy.
Secondary Objective:
- The secondary objective is to evaluate correspondence between changes of thermal signature of a normal organ, e.g. lung or esophagus, versus the toxicity of that organ from chemoradiation therapy.
Detailed Description
For Patients:
THERMAL IMAGER:
A thermal imager (a camera similar to a digital camera) takes pictures of skin surfaces. The imager is able to view temperature distribution of the skin surface.
STUDY PARTICIPATION:
If you agree to take part in this study, your body temperature will be measured with thermal imaging.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with lung cancers of any stages.
- •Patients will undergo chemotherapy or radiation therapy.
- •Patients with KPS > 70, are physically mobile and independent, and are able to stand still straight for more than 10 minutes for imaging purposes.
- •Age >18 years
Exclusion Criteria
- •Patients who had lung surgery within past 3 months.
- •Patients with breast implant or cardiac implant (pace maker or defibrillator).
- •Patients who had skin diseases (e.g. skin desquamation, dermatitis) or other medical conditions that may interfere with thermal measurement.
- •Pregnant woman
- •Extreme obese patients with body mass index >=35
Outcomes
Primary Outcomes
Change in Participant Thermal Signature as determined by Thermal imaging (recording body temperature)
Time Frame: Imaging session takes about 10 minutes to complete each time, imaging beginning at baseline and continuing till 12 months post therapy, up to 24 months
Body temperature at the time of the thermal imaging taken using a commercial infrared camera; thermal imaging sessions several times before the cancer treatment starts, during and after the radiotherapy courses. Using thermal images taken from multiple sessions, both the absolute and relative changes of the temperature distribution will be calculated and analyzed. The location of the regions will be guided by the diagnostic computed tomography (CT) and Positron Emission Positron emission tomography (PET)/CT images for temperatures at multiple angles of body, site of radiation for skin reaction, primary cancer site and critical normal organs.
Secondary Outcomes
- Number Toxicities Experienced by Participants according to CTCAE v. 3.0(Baseline to 24 months)